Cleared Traditional

K001584 - METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT

K001584 is an FDA 510(k) clearance for METROFOCAL TORIC (HIOXIFILCON A) SOFT (..., manufactured by Medvice Consulting, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K001584 · Medvice Consulting, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
22d
Days
Class 2
Risk

K001584 is an FDA 510(k) clearance for the METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (C.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Medvice Consulting, Inc. (Grand Junction, US). The FDA issued a Cleared decision on June 13, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001584

510(k) Number K001584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2000
Decision Date June 13, 2000
Days to Decision 22 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K001584.
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
K002647 · Marietta Contact Lens Service · Sep 2000
KONTUR 55 SOFT LENS
K001908 · Kontur Kontact Lens Co., Inc. · Aug 2000
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
K001227 · Opti-Centre Laboratories · Jun 2000
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
K001620 · Metro Optics of Austin, Inc. · Jun 2000
POLYMACON
K001089 · CooperVision, Inc. · May 2000
METHAFILCON A
K001090 · CooperVision, Inc. · May 2000
K001584 · METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT
Download PDF FDA Summary Medvice Consulting, I…